DECT in Imaging Patients With Solid Organ Cancer With Intracranial Metastasis

NCT ID: NCT03685539

Last Updated: 2023-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-24

Study Completion Date

2023-08-29

Brief Summary

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This trial studies how well dual energy computed tomography (DECT) works in imaging patients with solid organ cancer that has spread to the brain. Imaging techniques, such as DECT, may help find and diagnose tumor cells and find out how far the tumor cells have spread in the brain.

Detailed Description

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PRIMARY OBJECTIVES:

I. To optimize two major parameters of computed tomography (CT) imaging for optimal detection of intracranial metastatic lesions.

Ia. Virtual monochromatic image reconstruction. Ib. Contrast bolus timing. II. To measure the detection accuracy of CT compared to the diagnostic standard of care gadolinium-based "Gamma Knife (GK)" protocol magnetic resonance imaging (MRI).

OUTLINE:

Within 7 days before the standard Gamma Knife MRI, patients undergo DECT scan over 6 seconds at 1.5, 5, 10, and 20 minutes after receiving the contrast agent.

Conditions

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Malignant Neoplasm Metastatic Malignant Neoplasm in the Brain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (DECT)

Within 7 days before the standard Gamma Knife MRI, patients undergo DECT scan over 6 seconds at 1.5, 5, 10, and 20 minutes after receiving the contrast agent.

Group Type EXPERIMENTAL

Dual-Energy Computed Tomography

Intervention Type PROCEDURE

Undergo DECT

Interventions

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Dual-Energy Computed Tomography

Undergo DECT

Intervention Type PROCEDURE

Other Intervention Names

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DECT

Eligibility Criteria

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Inclusion Criteria

* Adult patient with pathology-proven solid organ cancer
* MRI of the brain with contrast, positive for two or more metastatic lesions

* One lesion with a single greatest diameter on contrast-enhanced MRI of 1 cm or greater
* Planned treatment with stereotactic radiosurgery

Exclusion Criteria

* Known allergy to iodine-based contrast agents
* Patients with glomerular filtration rate (GFR) less than 30 or use of hemodialysis
* If prior nephrectomy, GFR less than 60
* Prior central nervous system malignancy
* Prior brain radiation
* Pregnant women are excluded
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason M Johnson

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

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NCI-2018-01984

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018-0303

Identifier Type: OTHER

Identifier Source: secondary_id

2018-0303

Identifier Type: -

Identifier Source: org_study_id

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